Electrical Nerve Block for Amputation Pain

Tracking Information
First Submitted Date ICMJE	August 15, 2014
First Posted Date ICMJE	August 21, 2014
Last Update Posted Date	June 1, 2018
Actual Study Start Date ICMJE	October 9, 2014
Estimated Primary Completion Date	June 2020 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 23, 2018)	Primary Effectiveness Endpoint: Reduction of Pain Level by 50% from Baseline [ Time Frame: 3 months post implant ]Demonstration of 50% reduction in a Numerical Rating Scale (NRS) pain score from pre-treatment to post-treatment for more than 50% of all pain episodes. Study success will be determined by a superiority test on the difference between responder rates in the Test group (those receiving the treatment) and Control group (those who do not receive treatment).; Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events [ Time Frame: From consent through 3 months post implant ]Incidence of all serious adverse events including serious adverse device events and unanticipated adverse device events.
Original Primary Outcome Measures ICMJE; (submitted: August 19, 2014)	Pain reduction after each treatment session as measured by Numerical Rating Scale [ Time Frame: 3 months post implant ]; Incidence of all serious adverse events [ Time Frame: 3 months post implant ]
Change History	Complete list of historical versions of study NCT02221934 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 20, 2017)	Secondary Effectiveness: Pain Relief after 2 hours [ Time Frame: 12 months post implant ]Average percent change of pain intensity from before treatment, 30 minutes post treatment, and 2 hours post treatment; Secondary Effectiveness: Pain Days per Week [ Time Frame: 12 months post implant ]Average number of pain days compared at Month 3, Month 6 and Month 12 to Baseline.; Secondary Effectiveness: Pain Medication Use [ Time Frame: 12 months post implant ]Average morphine equivalent dose per day over two weeks compared at Month 3, Month 6 and Month 12 to Baseline.; Secondary Effectiveness: Pain Interference to Activities of Daily Living (ADL [ Time Frame: 12 months post implant ]Brief Pain Inventory summary score compared at Month 3, Month 6 and Month 12 to Baseline.; Secondary Effectiveness: Health-related quality of life (HR-QOL) [ Time Frame: 12 months post implant ]EQ-5D summary index, SF-12 physical component and mental component summary compared at Month 3, Month 6 and Month 12 to Baseline.; Secondary Effectiveness: Patient Global Impression of Change (PGIC) [ Time Frame: 12 months post implant ]Comparison of Patient Global Impression of Change across the Month 3, Month 6 and Month 12 office visits; Secondary Safety [ Time Frame: 12 months post implant ]Incidence of all Non-Serious Adverse Events, including Non-Serious Adverse Events, Non-Serious Adverse Device Events, and Unanticipated (Non-Serious) Adverse Device Events from the time of consent through 12 months post implant.
Original Secondary Outcome Measures ICMJE; (submitted: August 19, 2014)	Pain Medication Use [ Time Frame: 12 months post implant ]; Pain interference to Activities of Daily Living (ADL) [ Time Frame: 12 months post implant ]; Health-related quality of life (HR-QOL) [ Time Frame: 12 months post implant ]
Current Other Outcome Measures ICMJE; (submitted: September 20, 2017)	Exploratory Efficacy: Prosthetic Use [ Time Frame: 12 months post implant ]; Average hours of prosthetic use per week averaged across two weeks compared at Month 3, Month 6 and Month 12 to Baseline.
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Electrical Nerve Block for Amputation Pain
Official Title ICMJE	High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study
Brief Summary	The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation pain.
Detailed Description	The Altius System is an implanted device designed to electrically block nerve signals and alleviate pain. Use of this device may be associated with providing an effective, mechanism-based yet non-destructive, treatment for managing intractable limb pain in amputees. In a given patient, the Altius System will be deemed effective if treatment results in 50% reduction of pain score for more than 50% of all pain episodes.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Post-Amputation Pain; Phantom Limb Pain; Residual Limb Pain; Stump Pain
Intervention ICMJE	Device: Altius; Electrical signal
Study Arms	Experimental: Signal more likely to block nerve Electrical signal delivered to nerve by Altius, a device designed for high-frequency nerve block Intervention: Device: Altius; Active Comparator: Signal less likely to block nerve Electrical signal delivered to nerve by Altius, a device designed for high-frequency nerve block Intervention: Device: Altius
Publications *	Soin A, Shah NS, Fang ZP. High-frequency electrical nerve block for postamputation pain: a pilot study. Neuromodulation. 2015 Apr;18(3):197-205; discussion 205-6. doi: 10.1111/ner.12266. Epub 2015 Feb 5.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: May 22, 2018)	180
Original Estimated Enrollment ICMJE; (submitted: August 19, 2014)	130
Estimated Study Completion Date	September 2025
Estimated Primary Completion Date	June 2020 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Key Inclusion Criteria: Age ≥ 21 years old; Unilateral amputated leg ≥ 12 months; Chronic post amputation pain ≥ 6 months; Pain episodes typically lasting ≥ 60 minutes; Stable drug regimen ≥ 6 weeks; No changes to medications or prosthesis for 3-month primary study period Key Exclusion Criteria: Implanted with an active implantable medical device (i.e. pacemaker); Confounding source of pain that interferes with reporting of limb pain; Uncontrolled diabetes; Spasticity preventing full range of motion of involved side; Extremely short stump; sits on end; Untreated psychological condition (i.e. borderline personality); Condition requiring MRI studies or diathermy after device implant; Life expectance of less than 24 months; Progressive neurological disease (i.e. multiple sclerosis)
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Barbara S Lindsay blindsay@neurosmedical.com Contact: Matt Iorio 440-951-2565 ext 121 miorio@neurosmedical.com
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT02221934
Other Study ID Numbers ICMJE	003-0001; QUEST Trial ( Other Identifier: Neuros Medical )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Neuros Medical, Inc.
Study Sponsor ICMJE	Neuros Medical, Inc.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Leonardo Kapural, MD, PhD Center for Clinical Research, Winston-Salem NC
PRS Account	Neuros Medical, Inc.
Verification Date	May 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP